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FDA reins in Google-backed genetics company 23andMe

Health-related genetic test service put on hold pending US regulatory review
23andMe genetic testing kit

US-based 'personal genetics' company 23andMe has been forced to stop providing the public with health-related data until the service gets the all-clear from the FDA.

23andMe submitted its first application for FDA clearance in July 2012 and made another submission at the end of August but behind schedule with its responses, prompting a warning letter from the US regulator.

Responding to the FDA letter the Silicon Valley company said "we recognise that we have not met the FDA's expectations regarding timeline and communication regarding our submission".

Anne Wojcicki, co-founder and CEO of 23andMe, said: "We stand behind the data that we return to customers - but we recognise that the FDA needs to be convinced of the quality of our data as well.

"This is new territory for both 23andMe and the FDA. This makes the regulatory process with the FDA important because the work we are doing with the agency will help lay the groundwork for what other companies in this new industry do in the future. It will also provide important reassurance to the public that the process and science behind the service meet the rigorous standards required by those entrusted with the public's safety."

The Google-backed firm said its ancestry-related information and raw genetic data services would continue as before, but it's a major blow for the firm's mission to pioneer a new approach to genetic testing and research which will now have to wait for its tests to be approved by the FDA.

In the six years it has been running 23andMe has tested more 500,000 people and collected over 250 million survey data points, in the process building a crowd-sourced research database.

The company will continue to run its Parkinson's, sarcoma, MPN and African American research projects would continue, and plans to launch further research communities in 2014.

10th December 2013

From: Regulatory, Healthcare

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